Reforming NICE and the Cancer Drugs Fund – four key changes we want to see

Today, NHS England and NICE have set out their plans to reform the way they pay for and approve new cancer drugs. While we digest the new proposals, and before we respond, here are some of the key principles we want to see addressed, to make sure all patients are able to receive the best possible treatment.

And we’ve regularly expressed our frustration at the fact that, under the systems currently in place across the UK, doctors often can’t offer their patients the full range of evidence-based treatments available, to give them the best chance of beating their cancer.

That’s not to say there haven’t been well-intentioned plans. Most notably, in 2010, the Government recognised that the NHS needed a different approach to help more patients to have advanced cancer drugs that might benefit them. They promised two reforms:

They would look at the way drugs are priced in the UK

In the meantime, they would establish a Cancer Drugs Fund (CDF) in England as a temporary solution to allow cancer patients to have drugs that their doctors believe will benefit them

But these proved to be big challenges, and by early 2015, we still didn’t have a new system in place –meaning the CDF – intended as an interim fix – is still with us.

We think it’s unacceptable that after five years of conversation, there still isn’t an effective solution in place. This is despite the efforts of a range of organisations, including cancer charities such as ourselves, culminating in the recent Cancer Strategy stating clearly that:

NHS England should work with NICE, the Government, the pharmaceutical industry and cancer charities to define a sustainable solution for access to new cancer drugs.

The new process should be published for consultation in summer 2015, with a view to implementation from April 2016. The solution should set out reforms to NICE processes to make them more flexible for cancer drugs.

So we’re extremely pleased – and relieved – that today, NHS England and NICE have set out proposals to reform the system, which are now open for consultation.

We will need to look at these proposals in detail. But in the meantime, here are the changes we think are needed.

What should the way cancer drugs are funded look like?

We should stress that this is not just about reforming the Cancer Drugs Fund, but about reforming the system as a whole. Getting it right is going to be difficult, but we think there are a few important principles and considerations that might get us closer to a solution.

The ‘Early Access to Medicines Scheme’ should be expanded

Before drugs can be sold in the UK, they need a license – a process that can take many months to process. The Early Access to Medicines Scheme (EAMS) applies across the UK and has allowed some patients to receive two cancer drugs before they were licensed. Both of these drugs are new-generation immunotherapies which are showing tremendous promise.

EAMS has been useful in demonstrating how to make promising drugs available to patients, and speeding those drugs through the NICE appraisal process once licensed. We believe the scheme should be built upon and expanded. Of course, pharmaceutical companies, the Department of Health and the NHS will need to agree on a long-term sustainable way to pay for this (currently the pharmaceutical company donates these drugs to the NHS).

The Cancer Drugs Fund should become a time-limited way to pay for drugs between licensing and a NICE decision

At the moment, the EAMS system means a drug can be available for a short time, then withdrawn after it gets its licence, then made available again (or not) when NICE rules on cost-effectiveness. This means there can be a gap in time when a drug isn’t available, even though it’s effective.

On the other hand, drugs can be available through the Cancer Drugs Fund for a theoretically unlimited time – even after NICE rules ‘no’. And, quite shockingly, no data are collected on how patients fare after being given drugs paid for via the Fund.

So we think the CDF should be reworked into a way to pay for drugs in between their being licensed and NICE making a decision on cost, all the while capturing data on their effectiveness – so NICE can make more informed decisions.

NICE’s assessment processes should be subject to a fundamental review

We need to clarify how well NICE’s processes work for cancer drugs, both now and in a future when even more advanced treatments will be discovered.

NICE should be able to say ‘maybe’

We think NICE should be able to make temporary, conditional approvals that mean that:

Patients can benefit from drugs that are promising, but don’t have strong evidence, as early as possible;

Companies have to go away and collect more data on how their drugs are benefiting patients;

NICE can still say ‘no’ if the resulting data says the drug does not work well;

The price that companies pay would be managed during this time.

We also want to see wider changes to improve the funding system and ensure patients get the best drugs for them. These should include:

A national Molecular Diagnostic service, allowing tests to show whether the genetic mutations in a patient’s cancer mean they might respond well to new, targeted drugs, to be provided consistently to all relevant patients (we’ve written about this here)

A more flexible system of ‘Individual Funding Requests’ – where patients’ doctors can apply for exceptional funding for a drug that isn’t normally paid for, but might benefit their patient because of unique circumstances. The experts we’ve spoken to all agree it is extremely difficult to use this scheme, even for the most hard-to-treat patients.

What now?

We think these broad but fundamental changes will help more patients get the cancer drugs they need, and ensure that the NHS can afford these drugs now and in the future.

The proposals published today seem to focus predominantly on changes to the Cancer Drugs Fund, which only exists in England. But our suggestions for wider changes will have implications for the other UK countries – and we hope NICE and the governments of the devolved nations will consider these too.

Funding for cancer drugs is rarely far from the headlines and political debates. A long-term funding model is something we desperately need to get right. Partly, this is to make sure that the cancer patients of today can benefit from the best, evidence-based treatments available.

But we also need to make sure that the system can afford the promising treatments that will come through the research pipeline in future. The solution will be complex, and political commitments should not be rushed.

We’ll now be looking in detail at the reforms proposed today, and outline our thoughts on them when we’ve fully digested their implications. But above all we hope that, after all this time, NHS England, NICE – and later on the devolved Governments of the UK – can create faster, fairer funding systems, so that every single cancer patient has the chance to benefit from treatments that could help them.

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Hi Grusby,
We absolutely agree with you that more needs to be done to speed up clinical trials, and we’re working hard to improve things. We want all clinical trials – not just the ones that Cancer Research UK funds – to be set up and recruiting patients as soon as possible. This obviously needs to be balanced against the need to make sure they’re set up properly and safely, but we know that, overall, this can take a long time in the NHS – sometimes too long. That’s why we’re working with Government organisations like the Health Research Authority to improve the way clinical trials are approved, set up and regulated in the UK.

We’ve also been involved in campaigning for changes to European-wide regulation of clinical trials. As a result of this, a new law will come into force in 2017, which will make trials easier to set up in, and between, European countries, something which is especially important for childhood cancers and rare cancers.

This is all to be commended but when will something be done about the time it takes to get drugs into even a Phase 1 trial. I am a patient rep on four TMGs (Trial mgmt Groups). One started four years ago and still hasn’t reached final approval to go ahead because of delays by ethics committees, delays getting resources, especially IT, delays because funding was given then withdrawn after a year because it was taking too long, etc. The biggest killer in the NHS is bureaucracy which unfortunately can’t be used to cure or slow down cancer.

Time is on the side of money-saving politicians, not desperately ill people. This very modest set of recommendations should be agreed swiftly as the starting point for a 21st century programme of equitable cancer treatment.

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